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BIG PHYSICS, BIG QUESTIONS –

Publish and be applauded

By John Pearn and Iain Chalmers

IT’S the same story the world over&colon; researchers, as inveterate consumers of scientific reports, are overwhelmed by the sheer bulk of their reading matter. But some heads of research seem to feel that their departments are actually not publishing enough. The publishers, of course, do not demur. So it is hardly surprising that the question “Is your publication really necessary?” often appears in these pages and elsewhere.

The problem has certainly reached critical proportions in the biomedical field, which is now served by more than 16 000 journals. But publication of research that has involved human participants has important ethical dimensions making it a special case. For example, some ethics committees overseeing clinical trials on drugs and other biomedical products now require, as a condition of their approval, that investigators declare their intention to submit research results for publication. It is a practice which we endorse wholeheartedly. So an alternative form of that often asked question might be “Is failing to publish your research really ethical?”

Obviously, everyone would deplore the publication of invalid research in a field as vital as medicine. Invalid research might help to promulgate ineffective or harmful treatments. However, failure to publish well-conducted clinical research raises at least two important ethical issues. One relates to a higher order of control over research ethics committees which approve and monitor research involving human participants – particularly the detection of unethical practices. The second relates to the nonpublication of data which are potentially important for any and all of us, whether in the context of our use of the health services as patients, or our personal involvement in biomedical research.

Kay Dickersin and Yuan-I Min, epidemiologists at the University of Maryland, have convincingly shown recently that during the 1980s and early 1990s some clinical investigators were responsible for biased under-reporting of research (“Publication bias&colon; the problem that won’t go away”, in Doing More Good Than Harm, edited by K. S. Warren and F. Mosteller, Annals of the New York Academy of Sciences, vol 703, p 135, 1993). It seems that studies which have yielded relatively dramatic estimates of the beneficial effects of healthcare are more likely to be selected for presentation at scientific meetings, reported in print, published as full reports, published in journals that are widely read, and cited in reports of subsequent, related studies.

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In fact, publication bias in science was first investigated systematically by psychologists during the 1960s and 1970s, and the problem may well be widespread throughout science. Its consequences in some fields of scientific endeavour may simply be to retard the growth of knowledge, and waste resources. In an applied field of research such as healthcare, however, the consequences can be far more serious.

Selective under-reporting of clinical research – Dickersin and Min estimate the incidence to be one in ten – introduces both bias and imprecision into assessments of the effects of healthcare, and this phenomenon must inevitably mean that decisions taken about health care and health research are less well informed than they might otherwise be. The available evidence suggests that publication bias in clinical research tends to lead to a rosier than justified assessment of the benefits and safety of individual elements of healthcare.

In our view, investigators embarking on clinical research projects implicitly enter into a contract with the individual patients who are recruited to participate in clinical research, as well as with the bodies who ate funding it. We suggest that research-funding bodies and the vast majority of the patients participating in clinical research assume that their involvement is contributing to a growth in knowledge. This implied contract is violated by investigators who, having conducted well-designed research, fail to make the results of their investigations publicly available.

Standards and practices for monitoring clinical research, with its many ethical and other overtones, are currently in a phase of considerable change. In the evolutionary sense, the best of all worlds would be achieved by a priori insistence on publication – both by grant-awarding bodies and by research ethics committees. This would be followed by peer review prior to publication, and would then be audited by research ethics committees and funding bodies to discover the reasons for any default in publication. The reasons for such default, if known and corrected by ethics committees and funding bodies, could, we suggest, do much to protect public interests in these matters.